Director of Regulatory Affairs

Globl Hlth and Infect Disease-427801

Research Professionals

04/22/2024

05/13/2024

No

Permanent Staff (EHRA NF)

Director of Regulatory Affairs

EHRA Non-Faculty Research

01000269

NF0008065

Full-Time Permanent

1

40

North Carolina, US

Dependent on Qualifications

06/03/2024

A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation’s top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.

One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.

University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing of North Carolinians, and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service.

OUR VISION
Our vision is to be the nation’s leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.

OUR MISSION
Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.

Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.

Education: We will prepare tomorrow’s health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.

Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.

The Director of Regulatory Affairs is responsible for planning, implementation and oversight of ethics and regulatory operations for the Institute for Global Health and Infectious Diseases (IGHID) investigators conducting observational and clinical research protocols. The Director supervises the activities of approximately 10 regulatory support staff members. The mission for the Regulatory Affairs group is to protect all study participants and assist researchers in their ethical and regulatory needs to further science and the mission of IGHID.

The Director of Regulatory Affairs is responsible for assuring that investigators and protocols comply with International (ICH, Helsinki), Federal (FDA, OHRP, NIH), local requirements and sponsor requirements for the conduct of clinical research.

The research portfolio at the Institute currently includes projects in multiple countries including the United States, flagship sites in Malawi, Zambia, DRC, China, Vietnam and Liberia, as well as supported sites South Africa, Cameroon, Uganda, and Tanzania. Research protocols include studies on infectious diseases such as HIV, COVID, influenza, malaria, syphilis, tuberculosis, hepatitis B, ebola, lassa fever, zika, sapovirus and norovirus, and associated program evaluations and epidemiological studies. IGHID investigators also conduct international projects in the following disciplines: OB/Gyn, Oncology, Surgery and Psychiatry.

The Director provides oversight of IGHID regulatory personnel managing IRB applications in the US and globally. They work in a coordinating role with multiple domestic and international local and central IRBs. They are responsible for regulatory oversight and coordination of multicenter studies and network trials where UNC is the lead coordinating center.

The Director is responsible for regulatory management of information from multiple global sites and for development and oversight of tracking and storage systems, as well as preparation and presentation of reports to share with IRBs, investigators, and their research teams. The Director helps assess training needs at global sites and maintains regular communication with principal investigators, study teams, and regulatory authorities at these sites. They should have an awareness and appreciation for research in international settings and the contextual differences between cultures and practices. The Directors supports PIs with IRB reporting and provides guidance for navigating regulatory uncertainties and quandaries with the overseeing IRBs. The Director actively participates in regulatory submissions to the UNC Chapel Hill IRB and is responsible for developing a strong working relationship with IRB leadership.

Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity or professional-level background in sponsored research administration, will accept a relevant Bachelor’s degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution.

Expertise in Microsoft Office applications including SharePoint and familiarity with electronic regulatory and document storage systems. Must have working knowledge of Good Clinical Practices (GCP) and the Code of Federal Regulations (CFR) as it applies to research management. Must have strong attention to detail and organizational skills; excellent communication and interpersonal skills; and the ability to adjust priorities rapidly in a fast-paced environment.

Minimum of 5 years experience in clinical trials management that may include regulatory affairs, clinical trials coordination or clinical trials data management. Experience working on observational and clinical trials in an international setting(s) in preferred. Experience with a variety of IRB submissions including: use of a single IRB, reliance agreements, mutli-site studies, investigator initiated trials, E-IND/EAP, Unanticipated Problems, and FDA inspection preparedness of all regulatory files. The ability to attend virtual meetings during non-traditional work hours is a component of the position. The ability to periodically travel to international research sites for training and quality assurance reviews is preferred. Experience working with Part 11 compliant document systems preferred.

This position is designated as a Campus Security Authority in accordance with the Clery Act. This position will be required to report Clery crimes to the Clery Compliance Manager and complete annual training about reporting responsibilities.